LOS ALTOS, CA--(Marketwire - September 13, 2012) - TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today presented results from its Phase 1/2a trial evaluating the safety, tolerability, systemic exposure and pharmacokinetics of Luliconazole Solution (10%) in adults with moderate-to-severe distal subungual onychomycosis (DSO) of the toenails. The data were presented in a poster session during the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.
Study results showed that daily topical application of Luliconazole Solution (10%) to the toenails of 24 patients for 29 days followed by a 7-day follow-up period resulted in undetectable or very low drug levels near the limit of quantification (0.05ng/mL), and there was no evidence of drug accumulation. In addition, all enrolled patients completed the trial and experienced excellent local tolerability with no laboratory abnormalities or evidence of drug-induced cardiac abnormalities. The poster titled "Maximal Use PK Study of Luliconazole Solution, 10% in Subjects with Onychomycosis" was presented at the ICAAC meeting by Amir Tavakkol, Ph.D., senior vice president of clinical development and operations at TOPICA. A copy of the poster presentation from the ICAAC meeting can be found at: www.topicapharma.com.
"We are encouraged by these findings, which continue to demonstrate the potential for Luliconazole Solution (10%) to be an effective and safe topical therapy for onychomycosis," said Dr. Tavakkol. "These data further support our ongoing clinical development program for Luliconazole Solution (10%) which includes the recently initiated SOLUTION study, a Phase 2b/3 trial that is enrolling adults in the United States with mild-to-moderate DSO of the toenails."
About the Recently Initiated SOLUTION Study
The SOLUTION study is a randomized, double-blind, vehicle-controlled, multicenter trial assessing the safety and efficacy of Luliconazole Solution (10%) in two dosing regimens applied for 48 weeks. TOPICA expects to enroll approximately 300 patients with mild-to-moderate DSO of the toenail at approximately 20 centers in the United States. The primary endpoint of the trial is the number and percentage of patients achieving complete cure at week 52. Complete cure is a combined endpoint of clear nail based on clinical assessment and a fungal eradication assessment by KOH (potassium hydroxide staining) and mycologic culture. Complete cure is the primary clinical endpoint defined by the U.S. Food and Drug Administration (FDA) for the conduct of pivotal clinical trials of antifungal products seeking FDA approval for onychomycosis. For more information on the SOLUTION study visit clinicaltrials.gov at: http://clinicaltrials.gov/ct2/show/NCT01431820?term=topica&rank=1.
Luliconazole is one of the most potent and broad-spectrum topical prescription antifungal agents. In numerous rigorous, preclinical models of onychomycosis, luliconazole has demonstrated rapid penetration of full thickness human toenails (infected and healthy) reaching concentrations well in excess of the MIC 90 concentrations needed to eradicate the dermatophytes that most commonly cause onychomycosis. A preclinical data set and clinical profile from the company's Phase 1/2a study of Luliconazole Solution (10%) suggests that it has the potential to be an effective and safe topical therapy for onychomycosis.
TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole for onychomycosis in the Americas and Europe. Luliconazole, 1% cream and solution formulations were approved in Japan in 2005 for the treatment of tinea infections of the skin. To date, more than ten million patients have been treated with the product in Japan, where luliconazole is one of the leading topical anti-fungal prescription products for tinea infections.
More than 35 million Americans are estimated to suffer from onychomycosis, for which treatment options are limited. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion.
About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. is a privately held clinical research stage pharmaceutical company focused on developing luliconazole for the treatment of onychomycosis, fungal infections of the nail. The company is focused on conducting the Phase 2b/3 SOLUTION study, a robust dose finding and proof of efficacy trial with luliconazole in onychomycosis with the goal of making luliconazole the first highly effective and safe topical treatment for onychomycosis. For more information, please visit http://www.topicapharma.com.